January 8, 2008 / 4:46 PM / in 12 years

Some lab rats win reprieve as drug test dropped

LONDON (Reuters) - A lucky few laboratory rats and mice won a reprieve on Tuesday following an extensive European review of drug research practice, which found one standard safety test to be redundant.

A rat with sensors attached to its brain to record its memory is seen in a 2005 photo. A lucky few laboratory rats and mice won a reprieve on Tuesday following an extensive European review of drug research practice, which found one standard safety test to be redundant. REUTERS/Aly Song

Millions of animals will still be needed for medical research each year, but scientists said ending acute toxicity tests — designed to measure lethal doses in animals — was an important first step in reducing the burden.

Animal testing is an emotive subject, particularly in Britain, where small groups of protestors have conducted sometimes violent campaigns against companies and individuals involved in animal experimentation.

Just under half a million rats and mice are used in Europe each year to test the toxicity of new medicines, accounting for 4 percent of overall animal use. Dropping the acute toxicity test would save around 15,000 a year.

“While we recognize that this reduction represents a small proportion of the total, it is an important step in the right direction,” said Sally Robinson of AstraZeneca Plc, who led the review.

Robinson and colleagues concluded the single-dose acute toxicity test, which is traditionally required to identify the dose of a drug that causes a major toxic effect, was outmoded because of changes in the process of drug development.

Screening for harmful side effects using animals remains important, but simple acute toxicity tests are no longer needed before a new drug is tested in humans.

A total of 18 drug companies and Britain’s National Centre for the Replacement, Refinement and Reduction of Animals (NC3Rs) in Research pooled evidence from 2003 to 2007 for their research, which was published in the journal Regulatory Toxicology and Pharmacology.

The next step will be to change the regulations that require acute toxicity testing, according to Kathryn Chapman of the NC3Rs.

But, in practice, companies are already cutting back on the test without running into problems with the regulators.

Overall, firms involved in the review have reduced animal use in acute toxicity tests by more than 70 percent, suggesting there is even greater potential for reductions worldwide.

Other major drugmakers involved in the review included GlaxoSmithKline Plc, Novartis AG, Roche Holding AG, Sanofi-Aventis SA and Pfizer Inc.

Reporting by Ben Hirschler, editing by Will Waterman

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